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FDA denies a petition seeking Risk Evaluation and Mitigation Strategiesfor Behrings simultaneously approved Hemophilia B gene ther...[ Price : $8.95]
CDRH qualifies the CHemical RISk calculator Color Additives under its Medical Device Development Tools program.[ Price : $8.95]
The journal Science says safety questions are being raised about Eisai and Biogens lecanemab (BAN2401), an investigational anti-am...[ Price : $8.95]
FDA sends Spectrum Pharmaceuticals a complete response letter rejecting the companys poziotinib and its use in treating certain pa...[ Price : $8.95]
Federal Register notice: FDA announces a 1/9 Dermatologic and Ophthalmic Drugs Advisory Committee meeting to discuss a Regeneron P...[ Price : $8.95]
FDA alerts healthcare professionals about potential compatibility issues with prefilled glass syringes and certain Luer-activated ...[ Price : $8.95]
Federal Register notice: CDER proposes to withdraw the approval of an NDA 006499 for Bufferin (aspirin) tablets because it has not...[ Price : $8.95]
FDA clears a RapidAI 510(k) for the latest release of Rapid ICH, an intracranial hemorrhage (ICH) triage and notification device.